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Sympathomimetic Agent
Ephedrine for Childbirth
Phase 4
Recruiting
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study, at 6 months
Awards & highlights
Study Summary
This trial will study if ephedrine given before epidural anesthesia placement can reduce the number of Category II fetal heart rate tracings and low blood pressure due to labor analgesia.
Who is the study for?
This trial is for women aged 18-55 years in labor who want pain relief and can give informed consent. They must have a reassuring 'Category I' fetal heart rate before getting anesthesia. Women with suspected pre-eclampsia, non-reassuring 'Category II or III' fetal heart rates, or a history of high blood pressure cannot participate.Check my eligibility
What is being tested?
The study tests if giving ephedrine before combined spinal epidural anesthesia can prevent certain changes in the baby's heart rate and mother's blood pressure during childbirth. Ephedrine has been used safely for over 50 years but its preventive use here is new.See study design
What are the potential side effects?
Ephedrine may cause an increase in heart rate and blood pressure, which are actually part of its intended effects to improve uterine blood flow. The dose used is lower than what's typically given to treat low blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of study, at 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study, at 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of category II fetal heart rate tracing
Secondary outcome measures
Average HR changes
Average blood pressure changes
Incidence of antihypertensive treatment after ephedrine administration
+7 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EphedrineExperimental Treatment1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 7.5 mg ephedrine IV will be administered to the patient, 12 minutes later, a second dose of 7.5mg will be administered to the patient as long as the patient is not hypertensive (BP no greater than 140/90)
Group II: PlaceboPlacebo Group1 Intervention
3 minutes after the placement of a combined spinal epidural with 25 mcg fentanyl, 2.5cc 0.9% NS IV will be administered to the patient, 12 minutes later, a second dose of , 2.5cc 0.9% NS will be administered to the patient.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ephedrine
2016
Completed Phase 4
~26810
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
862 Previous Clinical Trials
525,476 Total Patients Enrolled
James LeaderStudy DirectorIcahn School of Medicine at Mount Sinai
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have chosen not to receive spinal or epidural anesthesia.I have a history of high blood pressure.I am a woman aged between 18 and 55.My baby's heart rate was normal before I received spinal or epidural anesthesia.My baby's heart tracing was not perfect before my spinal or epidural.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Ephedrine
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment accept applicants over the age of eighty?
"This medical study is open to individuals aged 18-55."
Answered by AI
Is there an opportunity to participate in this medical research?
"To be eligible, candidates of child-bearing age (18 to 55) are encouraged to apply. The research team aims to enrol 150 participants in total."
Answered by AI
Are there any adverse effects associated with Ephedrine use?
"Given the fact that this is a Phase 4 clinical trial, our team at Power has rated ephedrine's safety as 3. This signifies that it has been sanctioned for use by medical professionals."
Answered by AI
Are there still available slots for participants in this medical experiment?
"According to information obtained from clinicaltrials.gov, this medical trial is not actively accepting applications at present. Inaugurated on May 1st 2023 and last updated 23 days later, the trail has ceased recruiting patients for now; yet four other studies are still in search of volunteers."
Answered by AI
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